Ankle Braces for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Cerebellar stroke, Neurologic conditions, Sensorimotor neglect, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different ankle braces, specifically the Dynamic Ankle-Foot Orthosis, can improve walking in stroke survivors. The main goal is to determine the best way to customize these braces to individual needs and to develop guidelines for doctors to select the appropriate brace. Participants will test braces with varying levels of support to identify the most effective option. Individuals who had a stroke over six months ago, use an ankle brace, and experience ankle strength issues might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to the development of personalized treatment options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing ankle braces, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that these ankle braces are safe for stroke patients?

Research has shown that ankle-foot orthoses (AFOs), special braces for the foot and ankle, are generally safe for stroke survivors. One study found that these braces help people walk faster and with better balance. Another study reported improvements in posture and walking ability with AFO use. This indicates that AFOs are well-tolerated and do not cause major issues for most people. Importantly, they positively affect muscle function during walking, which is a good indicator of safety. AFOs support ankle movement without causing harm, making them a reliable option for improving mobility in stroke patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for mobility issues after a stroke, like traditional ankle braces, focus on providing support and stability to prevent falls and assist with walking. However, the Dynamic Ankle-Foot Orthosis sets itself apart by offering a more adaptive approach. This innovative brace is designed to dynamically adjust to the user's movements, providing both support and flexibility, which can enhance natural walking patterns. Researchers are excited because this could lead to improved mobility and comfort for stroke survivors, potentially speeding up rehabilitation and improving quality of life.

What evidence suggests that this ankle brace is effective for stroke recovery?

Research has shown that special braces called dynamic ankle-foot orthoses (AFOs) can help stroke patients walk better. Studies have found that these braces increase walking speed, the number of steps per minute, and the length of each step and stride. Adjusting the stiffness of these braces to fit individual needs has also improved movement. By reducing the effort needed for walking, these braces help stroke survivors move more easily. Overall, dynamic AFOs have proven to be a helpful tool in improving walking for those recovering from a stroke. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing difficulties with walking due to ankle joint issues. Participants should be able to walk at least some steps, even if assistance is needed. There's no specific mention of exclusion criteria in the provided information.

Inclusion Criteria

I have been prescribed an ankle-foot orthosis (AFO) by my doctor.

I can't do 25 standing heel-raises due to weakness.

I had a stroke more than 6 months ago.

Exclusion Criteria

Individuals with sensorimotor neglect

I have not had a heart bypass or heart attack in the last 3 months.

My MRI shows I had a stroke affecting the back part of my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will walk with a brace under five different assistance level conditions to determine the optimal customization method

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Ankle-Foot Orthosis

Trial Overview

The study tests different levels of stiffness in ankle-foot orthoses (braces) to find out which level helps improve walking the most after a stroke. It aims to create guidelines for clinicians on prescribing the right brace based on individual needs.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

The study involving 25 chronic post-stroke hemiparetic patients demonstrated that using prefabricated thermoplastic posterior leaf spring ankle foot orthoses (PLS-AFO) significantly improved balance, as indicated by an increase in Berg Balance Scale scores from 42.12 without AFO to 47.52 with AFO.

The use of PLS-AFO also reduced fall risk, with stability scores improving from 3.35 without AFO to 2.69 with AFO, highlighting its effectiveness in enhancing safety for patients with mild to moderate spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients. Cakar, E., Durmus, O., Tekin, L., et al.[2016]

A systematic review of 60 studies on ankle-foot orthotics (AFO) for individuals with stroke and cerebral palsy found that most interventions improved walking speed and ankle dorsiflexion, indicating their efficacy in enhancing mobility.

However, many studies lacked detailed information on the severity of lower limb impairments and other confounding factors, suggesting a need for more comprehensive research to better understand the impact of AFOs on knee stability and overall function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ankle-foot orthotic management in neuromuscular disorders: recommendations for future research. Chisholm, AE., Perry, SD.[2022]

The new anterior encased ankle foot orthosis (AEAFO) design effectively corrects hemiplegic gait problems by controlling foot inversion and ankle plantar flexion in patients with stroke and head injuries.

The AEAFO is easy to fabricate and readjust in occupational therapy clinics, showing promising preliminary results in terms of strength, durability, and clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low temperature plastic anterior encased ankle foot orthosis: construction and preliminary clinical results. Chang, JJ., Su, CY.[2016]

In a study involving 105 stroke patients, the therapist-made SWIFT Cast AFO was used significantly more during physical therapy sessions compared to conventional AFOs, indicating better integration into rehabilitation.

Despite higher usage of the SWIFT Cast, there was no significant improvement in walking speed compared to conventional therapy, suggesting that while it is a low-cost and adaptable option, it may not enhance recovery outcomes beyond standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial. Pomeroy, VM., Rowe, P., Clark, A., et al.[2022]

Ankle foot orthoses (AFOs) have been shown to positively impact ankle movement during the gait of individuals with hemiplegic stroke, particularly in the stance and swing phases.

The articulated passive AFO demonstrated better effects on certain gait parameters compared to non-articulated passive AFOs, but most studies only evaluated short-term effects, indicating a need for further research on long-term outcomes and comparisons among AFO designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different designs of ankle-foot orthoses on gait in patients with stroke: A systematic review. Daryabor, A., Arazpour, M., Aminian, G.[2019]

The Chignon orthosis significantly improved free-walking speed in chronic hemiplegic patients, achieving an average speed of 0.81 m/s compared to 0.64 m/s without any orthosis (p<0.001).

Both the Chignon and prefabricated ankle-foot orthoses (PAFO) reduced the mechanical work required during gait, but the Chignon orthosis also enhanced ankle kinematics, particularly at heel strike and toe-off, indicating better functional performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Chignon dynamic ankle-foot orthosis using instrumented gait analysis in hemiparetic adults. Bleyenheuft, C., Caty, G., Lejeune, T., et al.[2022]

In a study involving 23 individuals with unilateral hemiparesis due to stroke, the use of ankle foot orthoses (AFOs) significantly improved their functional stability, as measured by the Functional Reach Test, in all directions (p < 0.05).

The findings suggest that AFOs can play a crucial role in enhancing balance rehabilitation for stroke patients, indicating their potential as an effective intervention for improving postural stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of ankle foot orthoses in functional stability of individuals with stroke. Rao, N., Aruin, AS.[2017]

A study of 237 stroke patients using the Patient-Reported Outcome Measures Information System® revealed that their self-reported physical function (PF) was significantly impaired, with a mean T-score of 30.8, indicating they are two standard deviations below the general population average.

Factors such as the need for more supportive assistive devices, recent ankle problems, and greater living assistance were identified as predictors of worse self-reported PF, highlighting the importance of these characteristics in planning effective AFO interventions for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthotic Research Initiative for Outcomes aNalysis (ORION I): predictors of PROMIS PF for stroke survivors seeking orthotic intervention. DiBello, SA., Wurdeman, SR., Gorniak, SL.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6775434/

Effect of ankle-foot orthosis on functional mobility and ...

The aim of this study is to evaluate the impact of different types of ankle-foot orthosis functional mobility and dynamic balance in stroke patients.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0021929024004925

Passive-dynamic ankle-foot orthoses change post-stroke ...

These findings indicate that PD-AFOs reduce COT primarily through small changes in work across many lower limb constituents.

3.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01425-7

Customized passive-dynamic ankle–foot orthoses can ...

This work provides initial efficacy data for stiffness-customized PD-AFOs in individuals post-stroke and lays the foundation for future studies ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39069629/

Customized passive-dynamic ankle-foot orthoses can ...

This work provides initial efficacy data for stiffness-customized PD-AFOs in individuals post-stroke and lays the foundation for future studies ...

5.

nature.com

nature.com/articles/s41598-021-95449-x

Effectiveness of an ankle–foot orthosis on walking ... - Nature

AFO improves walking speed, cadence, step length, and stride length, particularly in patients with stroke. AFO is considered beneficial in enhancing gait ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11017542/

Effects of ankle–foot orthoses on gait parameters in post- ...

Ankle-foot orthoses (AFO) can improve gait posture and walking ability in post-stroke patients. However, the effect of AFO on gait parameters in ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2173580814001011

Effect of ankle-foot orthosis on postural control after stroke

All of these braces exert an effect on static and dynamic balance, walking speed, cadence, step length, and dynamic base. Prescribing AFOs to stroke patients ...

8.

journals.lww.com

journals.lww.com/jpojournal/fulltext/2025/07000/effectiveness_of_ankle_foot_orthoses_for_patients.11.aspx

Effectiveness of Ankle-Foot Orthoses for Patients with...

This study aims to compare three orthotic ankle joint designs in AFOs for patients with muscle weakness in the plantarflexors and/or dorsiflexors.

9.

mdpi.com

mdpi.com/2079-6374/14/12/595

Effect of Ankle-Foot Orthosis on Paretic Gastrocnemius and ...

These results suggest that AFOs positively influenced the contraction patterns of paretic ankle muscles during walking in stroke patients.